Is the Use of a Buprenorphine Transdermal Patch More Effective Than Oral Medications for Postoperative Analgesia After Arthroscopic Rotator Cuff Repair? A Randomized Clinical Trial.

Abstract

Background: Appropriate analgesic protocols for patients following arthroscopic rotator cuff repair remain controversial. Although transdermal buprenorphine patches might potentially provide better pain control and fewer side effects, it is worth noting that there is limited evidence for this given a lack of direct comparisons with oral pain regimens.

Questions/purposes: Among patients undergoing arthroscopic rotator cuff repair, and compared with an analgesic approach using oral tramadol plus celecoxib: (1) Does perioperative use of buprenorphine patches provide better pain relief by a clinically important margin? (2) Does perioperative use of buprenorphine patches improve shoulder joint function recovery? (3) Does perioperative use of buprenorphine patches have a lower frequency of adverse reactions?

Methods: This was a prospective, single-center, randomized controlled trial. We included patients who underwent arthroscopic rotator cuff repair for partial- or full-thickness rotator cuff tears < 3 cm in size in the anterior to posterior direction as estimated by preoperative MRI and excluded those who had obesity, were pregnant, had opioid dependence, had history of cardiac bypass surgery or ipsilateral rotator cuff repair, had allergies to trial medications, were taking anticoagulants or antidepressants, were being treated with other postsurgical pain management methods, or had severe liver or kidney dysfunction. Based on these criteria, 64% (72 of 112) of patients were eligible. The patients were randomly assigned into either the control group (oral tramadol and celecoxib) or the experimental group (buprenorphine patches). The control group received 100 mg of tramadol and 200 mg of celecoxib every 12 hours for 2 weeks after surgery. The experimental group received buprenorphine patches about 48 hours before surgery without any oral medication. A medication journal was given to the patients to self-report their compliance in taking the drugs. The dosage regimen adhered strictly to protocol. After enrollment, 11% (4 of 36) of patients in the control group and 17% (6 of 36) of patients in the experimental group could not be fully analyzed because of loss to follow-up or missing data. The surveillance period was 3 months, and there was no crossover between groups. The groups did not differ at baseline in terms of demographic parameters and relevant clinical characteristics, including age, gender, BMI, American Society of Anesthesiologists classification, tear size, concomitant procedures, and number of anchors. The outcomes were (1) numeric rating scale (NRS) for pain score at rest or with movement, which ranges from 0 to 10, where 0 indicates no pain, and 10 indicates the worst pain; (2) the American Shoulder and Elbow Surgeons (ASES) score for joint function, which ranges from 0 to 100, with higher scores indicating better shoulder joint function; and (3) the incidence of postoperative adverse reactions. We defined the minimum clinically important difference on the NRS as 2 of 10 points and on the ASES score as 15 of 100 points, based on anchor-based approaches reported in other studies.

Results: We found no clinically important between-group differences in NRS pain scores at any time point, either at rest or with movement. Likewise, we found no clinically important between-group differences in ASES scores at any time point. Postoperative dizziness or drowsiness (20% [6 of 30 patients] versus 44% [14 of 32 patients]; p = 0.04) and nausea (10% [3 of 30 patients] versus 34% [11 of 32 patients]; p = 0.02) during the hospital stay were slightly lower in the experimental group compared with the control group.

Conclusion: In this randomized trial, we found no clinically important advantages in pain or function to the use of buprenorphine patches after arthroscopic rotator cuff repair, and insufficient evidence exists to confirm whether the minor differences in transient side effects could justify the use of a new and largely untested analgesic approach in this context. That being so, we recommend against the routine use of buprenorphine patches for this indication. In general, we found that pain levels were low after the procedure in both groups. Future studies, therefore, should focus on the efficacy of buprenorphine patches for more invasive or more painful procedures.

Level of evidence: Level I, therapeutic study.